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Completed

NCT Number: NCT05041244

Negative Pressure Wound Therapy in Diabetic Wounds

Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment. Patient with DFU will be selected based on an eligible criteria and randomly assigned to intervention group or control group.

Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis A randomised controlled study is being proposed, where up to 100 participants will be recruited.

The wounds of participants in the intervention arm will be managed with 3 weeks of TNPW.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mauritius

Réduit, Moka District, 80837, Mauritius

About this study

Study Description: Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment

Objectives:

Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis

Endpoints:

Primary Endpoint:

Incidence of complete wound closure at 7, 14 and 21 days Time for complete wound closure Side and depth of diabetic ulcer at 7, 14, 21 days Extent of granulation tissue (Epithelialisation) (7- 21 days)

Secondary Endpoints: Hospital stay, readmission, rate of amputation and rate of infections and adverse events Number of dressing changes

Study Population: 50 patients in each arm (interventional and control) Chronic diabetic ulcers, Wagner's 2-3 Male and female Diabetes Mellitus without renal and liver impairment Age 18- 74 years Stable patients with Diabetic foot ulcer A G Jeetoo Hospital, Port-Louis and Souillac District Hospital

Phase: 2 Description of Sites/Facilities Enrolling Participants: The study will take place at the above mentioned units Approval has been received by the Regional Health Director and Consultant in Charge and the Ministry of Health and Wellness for A G Jeetoo Hospital and Souillac District Hospital.

Patients will be recruited from the Diabetes Clinic or the General Surgery Department.

Patients with chronic diabetic ulcer fulfilling the eligibility criteria Description of Study Intervention: Patients will be randomized to Negative Pressure Wound Therapy (TNPW) arm and conventional treatment arm offered at the above named hospitals. TNPW devices will be used in patients in the intervention arm for 3 weeks.

TNPW is described as a medical procedure which involves application of a dressing to the wound. The dressing is attached to a vacuum device that provides sub-atmospheric pressures which help in the removal of exudates to promote the healing process. Dressings will be changed weekly.

Study Duration: 12 months Participant Duration: Each participant will be followed weekly during the procedure then 3 monthly to assess wound healing and enquire about need for further treatment including admissions and long term adverse effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 - 75 years
  • In good general health as evidenced by medical history or diagnosed with diabetes mellitus or exhibiting signs of diabetic foot ulcers
  • Patients suffering from diabetic foot ulcer last more than 3 weeks
  • Patients with diabetes and presence of a foot wound for more than 3 weeks

Exclusion criteria

  • Patients under <18 years or above 75 years
  • Patients unable to provide consent
  • Patients suffering from chronic kidney disease or liver impairment or other chronic conditions
  • Patients on anticoagulants
  • Patients with non diabetic ulcers
  • Patients with severe peripheral vascular disease
  • Patients having contra-indication to negative pressure wound therapy

Treatment and study plan

Negative pressure wound therapy delivered through VAC

Device

Initial cycle: Continuous first 48 hours Subsequent cycle: Consider intermittent DPC (5 min ON/2 mins OFF) for rest of the therapy Target Target Pressure: 50-175mmHg, to be titrated for more drainage Dressing change interval: every week; need for more frequent dressing need to be evaluated. More frequent change of adaptic can be considered. (Adaptic is a layer of thin dressing that will be in direct contact with the wound to reduce the risk of maceration and adherence to the dressing)

Standard of care

Device

Participants in the control arm will have their dressings changed as per the current standard of care.

Effective management of DFU will depend on accurate diagnosis and assessment and appropriate debridement of non-viable tissues in patients from both arms Patients will be advised to continue off loading and any evidence of early infection should be promptly treated.

Other names: Hydrogel, foams, pad and other dressings

Primary outcomes

  1. Wound closure

    Time frame: 3 weeks

    Any wound closure or % reduction in size

Secondary outcomes

  1. Biomarkers

    Time frame: 3 weeks

    The amount of granulation will be determined macroscopically and microscopically through histology. Biomarkers such IL6 TNF and CD31/33 will be analysed from tissue specimens

  2. complete wound closure

    Time frame: 1 year

    the incidence of complete closure will be determined and compared between the intervention group and the control group

  3. Adverse events

    Time frame: 1 year

    Adverse events will include physical and psychological distress as well as infections and admissions to hospitals or recurrence of ulcer

Sponsors and collaborators

Lead sponsor

University of Mauritius

Other

Collaborators

  • Acelity
  • Higher Education Commission, Mauritius
  • Ministry of Health and Wellness, Mauritius

Registry information

Official study title

Identification of Biomarkers, Prognostic Indicators and Development of Novel Interface Devices for the Clinical Use of Topical Negative Pressure in Diabetic Wounds

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2021
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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